MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number KD-650Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Stenosis (2263)

Event Date 03/18/2021

Event Type  Injury  

Event Description

In the literature titled ¿real-world experience of endoscopic submucosal dissection for ulcerative colitis-associated neoplasia,¿ patients experienced adverse events after procedures using olympus devices.Case with patient identifier (b)(6) reports pcf-q260ji used in the procedures.Case with patient identifier (b)(6) reports gif-q260j used in the procedures.Case with patient identifier (b)(6) reports kd-650q used in the procedures.Case with patient identifier (b)(6) reports d-201-11804 used in the procedures.Case with patient identifier (b)(6) reports fd-410lr used in the procedures.Study background/aim: patients with ulcerative colitis (uc) have an increased risk of colorectal cancer.Some studies have recently investigated endoscopic resection of uc-associated neoplasia (ucan), but the indications for endoscopic resection of ucan remain controversial.This study sought to clarify the problems encountered in endoscopic submucosal dissection (esd) for ucan.Methods: seventeen lesions in 12 patients with ucan (ucan group) and 913 epithelial lesions in 824 control patients without uc (non-uc group) were evaluated.Both groups underwent esd between january 2010 and december 2017 at toranomon hospital, tokyo, japan.Treatment outcomes of the 2 groups were compared retrospectively results: univariate analysis showed that the mean tumor size was significantly smaller in the ucan group than in the non-uc group (25.1 ± 26.7 mm vs.31.9 ± 19.0; p = 0.0023); however, the r0 resection rate was significantly lower in the ucan group (70.6 vs.92.9%; p = 0.001).Multivariate analysis showed a significantly lower negative horizontal margin rate in the ucan group (odds ratio 11.3, 95% confidence interval 3.588¿34.525; p = 0.000).Conclusion: esd for ucan is associated with a low-negative horizontal margin rate.When performing esd for ucan, it is important to evaluate the accuracy of the ucan demarcation line, especially for flat lesions, using white-light imaging and chromoendoscopy as well as other modalities, including biopsy of surrounding tissues.Two of the 17 lesions (11.8%) were stenosed after esd; all lesions were treated with circumferential esd (table 3).One of the cases with stenosis after esd was a whitish, superficial elevated lesion extending from rb to ra.In this case, the anal side of the lesion was in contact with the squamous epithelium of the anus and was seen circumferentially.The oral side of the lesion had spread to ra for a maximum of two-thirds.Marking dots were placed with reference to the results of the peripheral biopsy done before esd.Esd was performed circumferentially on the anal side and involved three quarters of the circumference on the oral side.A total of 6 endoscopic balloon dilations were performed from 69 to 198 days after esd.In another case, esd was performed for a lesion with unclear margins in the sigmoid colon.Because the horizontal margin was positive pathologically, an additional esd procedure was per formed 10 days later.This patient underwent full-circumference esd that included the first esd ulcer.In total, 3 endoscopic balloon dilatations were performed in the 27¿ 46 days after the second esd.During a mean observation period of 28.5 months, the local recurrence rate was 0%, the synchronous tumor rate was 25.0%, and the metachronous tumor rate was 8.3%.There is no report of olympus device malfunction described in this study.

Manufacturer Narrative

This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.

Manufacturer Narrative

This report is being updated to report additional information provided by the author.New information is reported in b5.

Event Description

Update: new information provided by the author: no olympus device malfunctioned.No olympus device caused or contributed to the adverse events experienced by any patient in the study.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14346186
• MDR Text Key: 294672972
• Report Number: 8010047-2022-07955
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-650Q
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other